FDA recall D-397-2014

Product

Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.

Reason for recall

Presence of Foreign Substance; metal particulates were visually observed in the tablets.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-12-23

Report date

2014-01-15

Termination date

2014-08-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Corona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-397-2014